Kornimate/medical-research-clean huggingface dataset:
quadrupled semitendinosus graft in anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: randomized controlled trial comparing reconstruction of anterior cruciate ligament (acl) with autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. it is intended to specially evaluate if by using only the semitendinosus (st) tendon, the strength of the limb for hamstrings is affected different compared to using both gracilis and st.

data checks programmed by a third party after inclusion of participant number 10, 20, 30 and 42. this includes source data verification. simple size calculations estimating a difference of 50% in strength improvement between both groups at the six months follow-up visit. 80% power and 5% alpha error. strength measured with dynamometer, laxity with acl laxity tester and function with 3 scores: ikdc, tegner-lysholm and koos. missing data will be minimized by double checking when registering data. it might be necessary to increase sample size to 50 patients of intermediate analysis show it is necessary to find an statistically significant difference. trial could be stopped early if one intervention shows to be better in the intermediate analysis. these analysis will be conducted after the first 16 and 32 participants have been included.

Eligibility criteria:
inclusion criteria: * patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. they should be at least 16 years old. exclusion criteria: * multiligament injuries. re-ruptures of the acl.
decreasing environmental impact and costs of using inhalational anesthetic with a carbon dioxide membrane filter system

Conditions: Anesthesia; Inhalation; Vapor

Summary: efficient inhalational anesthetic delivery requires the use of low-flow air and oxygen to reduce drug waste and minimize workspace contamination and environmental pollution. currently, excess anesthetic gas is scavenged and removed from the operating room via the hospital ventilation system, where it is released into the atmosphere. co2 is removed from the anesthesia circuit by the use of co2 removal systems to prevent re-breathing and potential hypercarbia. carbon dioxide is currently removed using chemical granulate absorbers (cgas), which trap co2 in the granules that are later disposed of when absorption capacity is reached. they require replacement approximately every other day when used in moderate to high volume surgical centres, placing a costly burden on the healthcare system and environment (landfill). one of the more concerning downfalls of using cgas is the potential for the inhalational anesthetics to react with the granules and potentially produce toxic byproducts known as compounds a-e that are nephrotoxic and neurotoxic and require excess amounts of anesthetic gas to dilute. this excess use of anesthetics gases places a financial burden on the healthcare system and has a detrimental impact on the environment. the vast majority of the gases used are eventually released into the environment with little to no degradation where they accumulate in the troposphere and act as greenhouse gases. dmf medical has created memsorb, a new co2 filtration membrane. memsorb can remove co2 from the anesthesia circuit without the use of cgas, thereby eliminating the potential for toxic byproducts and allowing for significantly lower air and oxygen flow to be used, resulting in less use of inhalational anesthetics. memsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows co2 to leave the rebreathing system, while maintaining the inhalational anesthetic in the circuit. the lifespan of memsorb is at least 12 months, resulting in less particulate waste and a decreased cost to the healthcare system. we wish to evaluate the ability and efficacy of memsorb in removing co2 from the anesthesia circuit while maintaining physiologic minute volume ventilation, as compared to the traditional cgas in a variety of surgical procedures, patient populations, and anesthesia gas flows.


Eligibility criteria:
inclusion criteria: * asa i - iii * elective surgical procedure * laparoscopic surgery for study aim iii exclusion criteria: * asa \> iv * emergency surgery * severe respiratory disease (eg asthma) * raised intracranial pressure * regional anesthesia * absence of arterial line for study aim iii * self-reported pregnancy

Keywords: anesthesia inhalation vapour co2 absorber minimal flow anesthesia memsorb healthcare cost greenhouse gas environment healthcare
pharmacokinetics and metabolism study of radiolabeled bms-986142 in healthy male subjects

Conditions: Arthritis

Summary: this is an open-label, single-dose, study in healthy males. the primary objective is to assess the pharmacokinetics (pk), metabolism, and routes of elimination of a single oral dose of radiolabeled bms-986142 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * signed informed consent * target population: healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ecgs), physical measurements, and clinical laboratory tests * body weight of at least 50 kilograms (110 pounds); body mass index (bmi) between 18 to 32 kg/m2. exclusion criteria: * history of any chronic or acute illness including active tb in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. * vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug. * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population. * history of allergies and adverse drug reaction to any oral contraceptive compounds or bruton tyrosine kinase (btk) inhibitors. * participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.

Keywords: rheumatoid
a study to evaluate safety and effectiveness of g-poem for gastroparesis

Conditions: Gastroparesis

Summary: the purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (g-poem) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.


Eligibility criteria:
inclusion criteria: * symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration. * must have a mean total gastroparesis cardinal symptom index (gcsi) score of ≥ 3 at screening visit. * refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-ht3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone). * moderate to severe delay in gastric emptying, defined as \> 25% solid retained at 4 hours or \> 75% retained at 2 hours. the qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying. * no evidence of mechanical obstruction based on upper gi endoscopy or upper gi series in their medical history. exclusion criteria: * another active disorder which could explain symptoms in the opinion of the investigator. * gastric retention of solids at 4 hours \< 25% or \< 75% at 2 hours. * ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) glp -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider. * significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by child-pugh score of 10 or greater. * poorly controlled diabetes with hba1c of greater than 10% at time of screening. * new medications for gastroparesis-related symptoms started within 1 month prior to registration. * pregnancy or nursing. * failure to give informed consent. * any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study. * botox injection into the pylorus within 3 months prior to registration. * allergy to eggs or egg beaters and ensure.

Keywords: gastric peroral endoscopic pyloromyotomy (g-poem)
coin-b: controlled interruption of nucleos(t)ide analogue treatment in chronic hepatitis b infections

Conditions: Chronic Hepatitis B

Summary: in this study we will prospectively stop na in both caucasian and non-caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.

an estimated 290 million people worldwide are chronically infected with the hepatitis b virus (hbv). one fourth of untreated patients develop progressive liver damage and are at risk of liver-related death, which can be prevented by treatment with nucleos(t)ide analogues (na). these drugs efficiently suppress viral replication, but seroclearance of the virus, defined as loss of hepatitis b surface antigen (hbsag), is predicted to require an average of 36 to 52 years of treatment. cessation of na after long-term viral suppression in patients without hbv seroclearance might reduce costs and may even increase the chance of subsequent hbsag loss. we have recently shown in a retrospective multicentric international study, that caucasian ethnicity and off-treatment viral control are associated with hbsag loss after na cessation. in this study we will prospectively stop na in both caucasian and non-caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b * under continuous na treatment * \>= 18 years old and \<= 75 years * hbeag negative at start of treatment * hbv dna undetectable \>36 months or \ 48 months * alt \<= 80 u/l exclusion criteria: * fibrosis \>f2 * active coinfection with hcv, hdv or hiv * pregnancy or lactation * immunocompromised patients * ever hcc or family history of hcc * ever participated in hbv sirna therapeutic trials

Keywords: chronic hepatitis b
effect of smoking cessation on non-surgical periodontal therapy

Conditions: Periodontitis

Summary: the aim of this prospective study is to verify the efficacy of smoking cessation on non-surgical periodontal therapy in adult subjects with chronic periodontitis. smokers that were willing to quit received periodontal treatment and concurrent smoking cessation therapy. periodontal maintenance was performed every 3 months. a calibrated examiner, blinded to smoking status, assessed periodontal status, gathered demographic and behavioural information with a structured questionnaire and measured air carbon monoxide concentration measurements.


Eligibility criteria:
inclusion criteria: * subjects were willing to stop smoking * \>10 teeth * periodontitis (30% or more of their teeth with proximal cal ≥ 5 mm exclusion criteria: * systemic conditions considered as risk factors for periodontal disease, * periodontal therapy in the last 6 months * continuous systemic use of anti-inflammatory or steroidal drugs

Keywords: smoking cessation tobacco dental periodontal
a study of efficacy and safety of fesoterodine in vulnerable elderly subjects with overactive bladder

Conditions: Overactive Bladder

Summary: this study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (uui) episodes in vulnerable elderly subjects with overactive bladder (oab).


Eligibility criteria:
inclusion criteria: * male or female subjects 65 years of age or older * oab symptoms for at least 3 months * score 3 or greater on vulnerable elderly survey (ves-13) * adequate mobility for independent toileting * mean number of at least 2 uui episodes per 24 hours * mean urinary frequency of 8 or more micturitions per 24 hours * able to independently complete the bladder diaries exclusion criteria: * pvr urinary volume greater than 200 ml * mmse score less than 20 * greater than 15 uui episodes per 24 hours * creatinine clearance less than 30 ml/min * an average resting heart rate of greater than or equal to 90 beats per minute

Keywords: urgency urinary incontinence oab
effect of behavioral management on quality of life in heart failure

Conditions: Heart Failure

Summary: nurses play an important role in helping patients to manage symptoms, adhere to treatment, and change behavior. there has been a lack of research regarding nonpharmacologic interventions with patients with heart failure and other chronic conditions.

background: nurses play an important role in helping patients to manage symptoms, adhere to treatment, and change behavior. there has been a lack of research regarding nonpharmacologic interventions with patients with heart failure and other chronic conditions. objectives: the primary objective of this 4-year study was to determine the effect of a nurse-led behavioral management intervention on health-related quality in patients with medically-managed heart failure. the secondary objective was to assess the impact of the behavioral management intervention on health care resource utilization. methods: design: randomized controlled trial. setting: single site, va san diego healthcare system. sample: patients were enrolled in 11 cohorts a total of 116 outpatients were randomly assigned to one of two treatment groups to evaluate the clinical impact of the intervention. group 1 received usual care for patients with heart failure (n=58). group 2 was an augmented group receiving usual care plus participation in the 15-week (4-month) behavioral management program (n=58). inclusion criteria were that the patient had a primary diagnosis of heart failure, a va primary care provider, stable symptoms for at least one month and was able to walk. intervention: the behavioral management program augmented usual care and consisted of establishing specific goals with patients related to healthier diet, increased quality and amount of exercise, smoking cessation, and increased social and interpersonal activities. dependent variables/outcome measures: the five major dependent variables for this study were psychological symptom distress (multiple affect adjective check list - maacl), physical functioning (sf-36 physical component summary score), mental functioning (sf-36 mental component summary score), exercise capability (6-minute walk), and general health perceptions (sf-36 general health scale score). dependent variables were assessed at baseline, at the end of treatment (at 4 months), and then at 10 and 16 months. data analysis: initial analyses included all subjects who were randomized to treatment and completed all data collection time points in a series of 2 by 4 anovas with time as a repeated measure. status: completed. final report submitted august 2003

Eligibility criteria:
inclusion criteria: inclusion criteria are that the patient has a primary diagnosis of dilated cardiomyopathy or heart failure, a va primary care provider, stable symptoms for at least one month and is able to walk. exclusion criteria:
health of young european families and fish consumption

Conditions: Overweight; Metabolic Syndrome X; Bone Resorption

Summary: this is a controlled, randomized, intervention trial (crit) with 20-40 year old overweight individuals (n = 320) across europe in order to distinguish between biologically active components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk factors for metabolic syndrome, bone health, and weight management.

subjects were recruited through advertisements from october 2004 until april 2005. recruitment of 320 subjects (140 from iceland, 120 from spain, and 60 from ireland). the inclusion criteria were body mass index (bmi) 27.5 to 32.5 kg/m2, age 20-40 years, and a waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively. exclusion criteria were weight change due to weight loss diet within 3 months before the start of the study, use of supplements giving n-3 fatty acids, calcium or vitamin-d during the last three months, drug treatment of diabetes mellitus, hypertension or hyperlipidemia and women's pregnancy or lactation. each subject was instructed to follow a diet, energy-restricted by 30% from estimated energy expenditure (approximately 600 kcal/day), for 8 consecutive weeks. the subjects were randomly assigned to four diets varying in types of dietary protein and amount of n-3 fatty acids (especially very long chain n-3 fatty acids): i: no seafood (control, including 6 placebo capsules/day) ii: lean fish (150 g cod x 3/week) iii: fatty fish (150 g salmon x 3/week) iv: fish-oil capsules (6 capsules/day) risk factors for metabolic syndrome, bone health and weight management were analysed at baseline and endpoint.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 27.5 to 32.5 kg/m2 * ages 20-40 years * waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively exclusion criteria: * weight change due to weight loss diet within 3 months before the start of the study * use of supplements giving n-3 fatty acids * calcium or vitamin d during the last three months * drug treatment for diabetes mellitus * hypertension or hyperlipidemia * women's pregnancy or lactation

Keywords: overweight metabolic syndrome
liver transplantation for unresectable gist liver metastases

Conditions: Liver Diseases; Liver Cancer; Liver Metastases; Liver Neoplasms; Liver Mass; Liver Carcinoma; Liver Transplant; Complications; Liver Transplant Disorder; GIST; GIST, Malignant; Gastrointestinal Stromal Tumors; Gastrointestinal Stromal Tumor of Duodenum; Gastrointestinal Stromal Tumor of Rectum; Gastrointestinal Stromal Tumor of Other Sites; Gastrointestinal Stromal Tumor, Unspecified Site; Gastrointestinal Stromal Tumor of Stomach; Gastrointestinal Stromal Tumor of Esophagus (Disorder); Gastrointestinal Stromal Tumor by AJCC V8 Stage; Gastrointestinal Stromal Tumor, Malignant; Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract; Gastrointestinal Stromal Tumor of Small Intestine (Disorder); Gastrointestinal Stromal Tumor of Large Intestine (Disorder); Metastases to Liver; Metastatic Liver Cancer; Metastasis; Metastases; Liver Transplantation; Transplant Oncology

Summary: liver transplantation for unresectable gist liver metastases


Eligibility criteria:
inclusion criteria: * gist diagnosis (c-kit, cd34, dog-1) * imatinib-sensitive mutation * non-resectable liver metastases * abscence of extrahepatic disease * period greater than two years between primary tumor and metastases diagnosis

Keywords: liver transplantation gastrointestinal stromal tumor (gist) transplant oncology liver neoplasms liver metastases
fluorouracil, semustine, and vincristine compared with bcg in treating patients with dukes' b or dukes' c colon cancer that has been removed by surgery

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy, such as vincristine, fluorouracil, and semustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. biological therapies, such as bcg, may stimulate the immune system in different ways and stop tumor cells from growing. it is not yet known whether combination chemotherapy is more effective than bcg in treating colon cancer that has been removed by surgery. purpose: this randomized phase iii clinical trial is studying giving fluorouracil together with semustine and vincristine to see how well they work compared with giving bcg in treating patients with dukes' b or dukes' c colon cancer that has been removed by surgery.

objectives: i. obtain information to define subsets of colon cancer patients at high risk of recurrence. ii. correlate pathologic and biologic parameters with disease-free interval and survival. iii. determine the value of surgical and ancillary techniques in management of colon cancer. iv. compare disease-free interval and survival after curative resection vs. chemotherapy with 5-fluorouracil/methyl-ccnu/vincristine vs. bcg immunotherapy. v. relate the total lymphocyte count to the course of the disease. vi. determine the feasibility of conducting a trial employing immunotherapy in a surgical adjuvant setting. vii. identify appropriate future protocols based on data generated in the study. outline: randomized study for patients with dukes stage b and c disease only. all patients with dukes a and d lesions enter arm i. arm i: no therapy following surgery. arm ii: 3-drug combination chemotherapy. 5-fluorouracil, 5-fu, nsc-19893; methyl-ccnu, meccnu, nsc-95441; vincristine, vcr, nsc-67574. arm iii: immunotherapy. bcg-pasteur, bcg, nsc-b116328. projected accrual: protocol closed february 1984.

Eligibility criteria:
disease characteristics: see general eligibility criteria patient characteristics: see general eligibility criteria

Keywords: stage ii colon cancer stage iii colon cancer
effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds.

Conditions: Surgical Wound

Summary: surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. absorbable sutures can produce unwanted side effects when the body produces a reaction to them. the investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. if participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. the other half of the wound will be closed with non-absorbable stitches and tissue glue. the appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.


Eligibility criteria:
inclusion criteria: * age 18 years or older * postoperative defects of at least 3 cm, resulting from either mohs micrographic surgery or surgical excision * willing to give informed consent and return for follow-up visits 3 months and 6 months following surgery exclusion criteria: * pregnant * unable to understand english * mentally impaired * incarcerated * has nonlinear closures

Keywords: surgical wounds tissue adhesive sutures wound healing